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Mild to Moderate COVID-19Phase 3NCT06197217

Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19

A Phase 3 study testing WPV01 in people with Mild to Moderate COVID-19, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a multicenter, randomized, double-blind, placebo-controlled efficacy, safety Phase III clinical trial designed to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mild to Moderate COVID-19
What is being tested?
WPV01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,350 participants
Where
1 siteChina
Study dates
14 Jun 2023to 20 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥18 years at the time of signing informed consent, those with a history of COVID-19 were also eligible for enrollment in this study
  • Meet the diagnostic criteria for mild or moderate COVID-19 infection according to the the Diagnostic and Treatment Program for COVID-19 Infections (Trial Tenth Edition) issued by the China Health and Wellness Commission:
  • Positive for SARS-CoV-2 nucleic acid or positive for SARS-CoV-2 antigen in a nasopharyngeal swab specimen within 72 hours prior to randomization
  • The onset of a COVID-19-related target symptom is less than 72 hours from randomization and the presence of at least 1 of the 5 key COVID-19-related symptoms with a severity of ≥2 points on the day of randomization
  • Females of childbearing potential (details are defined in Appendix 3) Subjects must have a negative pregnancy test at Screening. Subjects will be required to use effective contraception throughout the study period beginning with the signing of the informed consent form and for 30 days after completion of the study.
  • Eligible to understand the procedures and methods of this clinical trial, with full informed consent and voluntary participation by the subjects.

Who cannot join

  • Known allergy to any of the ingredients in the investigational therapeutic agents
  • Meet the diagnostic criteria for severe or critical COVID-19 infection according to the Diagnostic and Treatment Program for COVID-19 Infections (Trial Tenth Edition) issued by the China Health and Wellness Commission at the time of randomization.
  • Within 14 days prior to randomization, the subject has received SARS-CoV-2 antiviral therapy or immunotherapy including, but not limited to, antiviral medications (e.g., interferon, raltegravir, lopinavir/ritonavir, favipiravir, ribavirin, chloroquine phosphate, arbidol, nirmatrelvir/ritonavir, molnupiravir, azulfidine, simnotrelvir/ritonavir, deuremidevir, and COVID-19 therapeutics approved during subsequent studies), corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulins
  • Within 3 days or 5 drug half-lives (whichever is longer) prior to randomization, the subject has used medications to alleviate symptoms of COVID-19: including, but not limited to, antipyretic/analgesic, cough suppressant/expectorant, compounded cold and flu remedies, antihistamines, anti-bacterials and anti-fungals
  • Abnormal liver function at screening: total bilirubin ≥ 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN
  • Being on dialysis or having a combination of moderate to severe renal insufficiency
Show all 17Show fewer
  • Immunocompromised at screening (including patients with malignant tumors, organ or bone marrow transplantation, or treatment with corticosteroids or other immunosuppressive agents)
  • Chronic respiratory disease, including bronchial asthma, chronic obstructive pulmonary disease, at the time of screening
  • Suspected or confirmed acute systemic infections other than COVID-19 at the time of screening
  • Any comorbidity requiring surgery within 14 days prior to randomization, or any comorbidity considered life-threatening by the investigator within 30 days prior to randomization
  • Patients who have received (within 30 days prior to randomization or within 5 drug half-lives, whichever is longer) or are expected to receive plasma therapy with SARS-CoV-2 monoclonal antibody or recovered COVID-19 during the study period
  • Patients who have received any COVID-19 vaccine within 1 month prior to randomization
  • Currently using or within 4 days post dose expected to use any drug or substance which are highly dependent on clearance via CYP3A4, MDR1, OAT1, or OAT3; used within 28 days prior to randomization or expected to use during the treatment drus with strong MDR1 inducer
  • Patients who have difficulty in swallowing or history of gastrointestinal disorders that significantly affect the absorption of drugs
  • Pregnant, lactating women
  • Participated in other interventional clinical trials or use of experimental drugs within 1 month prior to administration;
  • Patients who are judged by the investigator to be unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • China Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of WPV01 in Patients With Mild to Moderate COVID-19

The study is a multicenter, randomized, double-blind, placebo-controlled efficacy, safety Phase III clinical trial designed to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19.

Being tested
WPV01, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WPV01Drug

    Subjects in the WPV01 group will receive WPV01 600mg orally (200mg, 3 tablets per dose), 3 times daily (TID) for 15 consecutive treatments

  • PlaceboDrug

    Subjects in the Placebo group will receive WPV01 Placebo orally (3 tablets per dose), 3 times daily (TID) for 15 consecutive treatments

Study groups in NCT06197217
Study groupRoleWhat they receive
WPV01ExperimentalNot described
Receives: Drug: WPV01
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days

    Measured: Day 1 to Day 28

Secondary outcomes (16)

  1. Decrease in viral load from baseline on Day 5 of treatment

    Measured: Day 1 to Day 28

  2. Percentage of subjects achieving sustained clinical recovery of 11 COVID-19 symptoms at Day 5, 9, 14, 21, and 28

    Measured: Day 1 to Day 28

  3. Time to sustained clinical remission of 11 COVID-19 symptoms within 28 days of treatment

    Measured: Day 1 to Day 28

  4. Percentage of subjects achieving sustained clinical remission of 11 COVID-19 symptoms on Day 5, 9, 14, 21, and 28

    Measured: Day 1 to Day 28

  5. Changes in 11 COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28

    Measured: Day 1 to Day 28

  6. Time from first dose to sustained clinical recovery of 5 key COVID-19 related symptoms within 28 days

    Measured: Day 1 to Day 28

  7. Percentage of subjects achieving sustained clinical recovery of 5 key COVID-19 related symptoms at Day 5, 9, 14, 21, and 28

    Measured: Day 1 to Day 28

  8. Time to sustained clinical remission of 5 key COVID-19 related symptoms within 28 days

    Measured: Day 1 to Day 28

  9. Changes in 5 key COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28

    Measured: Day 1 to Day 28

  10. Percentage of subjects who experienced COVID-19 progression within 28 days

    Measured: Day 1 to Day 28

  11. Proportion of subjects requiring supplemental oxygen within 28 days

    Measured: Day 1 to Day 28

  12. Change in World Health Organization (WHO) Clinical Progress Scale Score within 28 days

    Measured: Day 1 to Day 28

  13. Time from first dose to SARS-CoV-2 RNA below the threshold after treatment within 14 days

    Measured: Day 1 to Day 14

  14. Percentage of subjects with SARS-CoV-2 RNA below the threshold on Day 3, 5, 7, 9 and 14

    Measured: Day 1 to Day 14

  15. Change from baseline in viral load at each visit from treatment to Day 14

    Measured: Day 1 to Day 14

  16. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start14 Jun 2023
  3. Primary completion21 Aug 2023
  4. Study completion20 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06197217
Sponsor's protocol ID
WPV01-CP-23
Status last verified
Jun 2024
First submitted
8 Jan 2024
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing WPV01 in people with Mild to Moderate COVID-19, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06197217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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